Recruiting

Venous Thromboembolism

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT02978950

Conditions

Venous Thromboembolism

Deep Vein Thrombosis

Trauma, Multiple

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Duplex ultrasound surveillance

No ultrasound surveillance

Study Details

Brief summary:

This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Once identified and enrolled, subjects will be randomized to receive bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and major and clinically relevant bleeding episode rates, both during the index hospitalization and at 90 days post-discharge.

Conditions

Venous Thromboembolism

Deep Vein Thrombosis

Trauma, Multiple

Study ID

NCT02978950

Start date

Mar 20, 2017

Status verified date

Nov, 2018

Completion date

Jun, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.
2. Age ≥18 at the time of injury
3. Meets the definition of high-risk for VTE according to current IMC trauma service guidelines

Exclusion Criteria:

1. Patient age <18 years at the time of admission to the hospital
2. Pregnancy
3. Prisoners
4. Patients with a life expectancy of less than 30 days
5. Patients with a known hypercoagulable state including:

  • Factor V Leiden
  • Protein C and S deficiencies
  • Dysfibrogenemia of any sort
  • Active cancer
  • Antiphospholipid antibody syndrome
  • History of DVT or PE within past 6 months
  • Myeloproliferative disorders
6. Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
7. Patient elects to opt-out of the study

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Surveillance arm

Bilateral duplex ultrasound surveillance

active comparator: No surveillance arm

no duplex ultrasound surveillance

Interventions

Duplex ultrasound surveillance

bilateral lower extremity venous duplex

No ultrasound surveillance

will have daily exam and history as per normal clinical routine

Primary outcome measure

  • Asymptomatic lower extremity DVT [ Time Frame: during index hospitalization, up to 2 weeks ]

Central Contacts and Locations

Central contacts

Brent Armbruster

801-507-4605brent.armbruster@imail.org

Valerie Aston, MBA, RT

801-507-4606Valerie.Aston@imail.org

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84157

Contacts

Valerie Aston, MBA, RT

801-507-4606Valerie.Aston@imail.org

Brent Armbruster

801-507-4605Brent.Armbruster@imail.org

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Nov 29, 2018

Last verified

Nov, 2018

Keywords

  • duplex ultrasound
  • trauma
  • venous thromboembolism
  • prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2018-11-29.